Skip to main content

Xarelto: “One Size Does NOT Fit All”

Injury lawsuits, such as the ongoing litigation against Bayer AG and Johnson & Johnson's Janssen division over the anticoagulant medication Xarelto, are based on what is known as a “cause of action.” In other words, the court wants to know what it was that resulted in the plaintiff's injury.

Broadly speaking, Xarelto is alleged to have caused uncontrolled bleeding in a number of patients, resulting in pain, suffering and death. However, the problem is even more specific than that.

A big selling point for the “new generation” anticoagulants was its simplicity: whereas the old treatment, warfarin, had many potential interactions, requiring frequent (and expensive) patient monitoring, the new treatments had relatively few interactions. Warfarin patients must also keep track of their INR. Short for “International Normalized Ratio,” this is a measure of how long it requires blood clots to form. INR determines the amount of medication the patient should take and serves as a guide to adjusting dosage. 

There were two issues in which the drug companies responsible for the new anticoagulant Xarelto went wrong. First of all, once a patient starts hemorrhaging, there is virtually no way to stop it. Presently, there is no reversal agent for what are known as “Factor Xa [10-a] Antagonists.” While such an antidote is currently being studied, it has not yet been approved for the market.

The second issue is related to the first. In its market promotions, Bayer stated that when it came to dosage, Xarelto offered a “one size fits all” approach. There was supposedly no need to bother with INR measurements. Xarelto tablets are available in three different strengths (10 mg, 15 mg and 20 mg); the only consideration for the physician was the specific risk factor – DVT prophylaxis (deep vein thrombosis prevention) for joint replacement, non-valvular atrial fibrillation (heart arrhythmia), or pulmonary embolism (blood clots in the lungs).

Simple, right? An added advantage was that patients would be more likely to take the medication if they didn't have to deal with the inconvenience of monitoring their INF.

Not really. A research study, published in Thrombosis Journal in February 2014, demonstrated that the risk of fatal bleeding in patients treated with Xarelto was directly related to the size of the dose. The researchers stated that:

[T]herapeutic excesses can condition bleeding risk and therapeutic limitation can increase thrombotic risk, especially when short-acting drugs such as the new oral anticoagulants are used. . . . [I]t is imperative to establish an appropriate method for monitoring new oral anticoagulants, setting levels of safety and effectiveness through periodic dosage and monitoring of their anticoagulant effects. Therefore, we still recommend the use of anticoagulation units [INR] for monitoring during treatment with the new oral anticoagulants. (Altman, 2014).

Apparently, Bayer either didn't know about this recommendation (highly unlikely), or disregarded it (very likely).

It wasn't the only time medical researchers had sounded the alarm. In March of 2015, Dr. J. Robert Powell published an editorial in the Journal of the American Medical Association in which he stated:
 

Even though the one-size-fits-all DOAC [Direct-acting Oral  AntiCoagulant) dosing may perform as well or better than warfarin on average, evidence suggests that patient safety can be further improved through individualized dosing.

Lawyers representing those injured by taking Xarelto believe Bayer and Janssen had an ethical and legal obligation to be aware of these concerns, and either they willfully or negligently failed in this obligation. To read more about the Xarelto litigation, visit Levin Papantonio’s Xarelto lawsuit web page.

Customize This